MedTrace Logo

Relative Bioavailability Trial of Dapivirine Ring-004 and Ring-008

NCT05416021 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 124

Last updated 2024-07-03

No results posted yet for this study

Summary

A Phase I, Open-Label, Randomized, Crossover Trial to Investigate the Relative Bioavailability of the 25 mg Dapivirine Vaginal Ring-004 inserted every 30 days and 100 mg Dapivirine Vaginal Ring-008 inserted for 90 days in Healthy Female Participants

Conditions

  • HIV Infections

Interventions

DRUG

dapivirine

dapivirine vaginal ring

Sponsors & Collaborators

  • International Partnership for Microbicides, Inc.

    lead INDUSTRY

Principal Investigators

  • Anél Dr Pretorius, MB ChB · FARMOVS Pty Ltd, Bloemfontein, South Africa

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-08-01
Primary Completion
2024-04-02
Completion
2024-07-02
FDA Drug
Yes

Countries

  • South Africa

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05416021 on ClinicalTrials.gov